NCT05330351

Brief Summary

Gastric ultrasound has become increasingly utilized to examine volume and quality of gastric contents in the preoperative setting to guide anesthetic management and relay risk of aspiration in both adult and pediatric medicine. Gastric fluid volumes in trauma patients are thought to be elevated due to delayed gastric emptying in the setting of an over-attenuated sympathetic response to physical pain and stress, opioid analgesia, and other associated injuries (traumatic brain). However, there is a paucity of literature examining gastric fluid volumes (GFV), measured by gastric ultrasound, in the pediatric trauma population. The purpose of the study is to assess whether preoperative gastric ultrasound is an accurate method to identify pediatric trauma patients who have elevated GFV (\>0.8mL/kg) and high-risk gastric contents (solids, complex liquids, in addition to large volumes).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2022Dec 2026

First Submitted

Initial submission to the registry

March 14, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

March 26, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

4.8 years

First QC Date

March 14, 2022

Last Update Submit

February 18, 2026

Conditions

Trauma; ComplicationsAspiration

Keywords

pediatrictraumagastricultrasound

Outcome Measures

Primary Outcomes (1)

  • Gastric fluid volume (GFV)

    GFV will be estimated via obtained gastric antral cross-sectional area (CSA), measured by ultrasound, and calculated using the formula: GSV= 0.0093 \* CSA \[mm2\] - 0.96. This calculated GFV will be compared to aspirated gastric volumes.

    GFV will be measured immediately prior to induction of general anesthesia within the operating room.

Secondary Outcomes (2)

  • Airway management patterns

    This data will be collected up to 1 year.

  • Aspiration

    This data will be collected up to 1 year.

Study Arms (1)

Pediatric Trauma Patients

Pediatric patients (\<18 years old) who have suffered a traumatic event requiring surgical fixation within 48 hours prior to time to arrival in the operating room.

Diagnostic Test: Gastric Ultrasound

Interventions

Gastric UltrasoundDIAGNOSTIC_TEST

The investigators will compare gastric fluid volume as determined by ultrasound pre-induction vs. gastric volume aspirated via an orogastric tube post-intubation. The results will be stratified into low risk, moderate risk and high risk for aspiration based on ultrasound exam by an investigator off-line.

Pediatric Trauma Patients

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

perioperative pediatric trauma patients

You may qualify if:

  • Pediatric patients ages 0-17 years-old
  • Patients suffering from a traumatic injury requiring urgent or emergent surgery.
  • Inpatient or Same-Day Surgery

You may not qualify if:

  • Children with altered or abnormal gastric physiology, ie, history of Nissen Fundoplication, history of short-gut syndrome, history of bariatric surgery/gastric sleeve, history of gastroparesis or functional dysmotility, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (11)

  • Hardman JG, O'Connor PJ. Predicting gastric contents following trauma: an evaluation of current practice. Eur J Anaesthesiol. 1999 Jun;16(6):404-9. doi: 10.1046/j.1365-2346.1999.00513.x.

    PMID: 10434171BACKGROUND

  • Schurizek BA, Rybro L, Boggild-Madsen NB, Juhl B. Gastric volume and pH in children for emergency surgery. Acta Anaesthesiol Scand. 1986 Jul;30(5):404-8. doi: 10.1111/j.1399-6576.1986.tb02439.x.

    PMID: 3766097BACKGROUND

  • Power I, Easton JC, Todd JG, Nimmo WS. Gastric emptying after head injury. Anaesthesia. 1989 Jul;44(7):563-6. doi: 10.1111/j.1365-2044.1989.tb11442.x.

    PMID: 2774121BACKGROUND

  • Warner MA, Meyerhoff KL, Warner ME, Posner KL, Stephens L, Domino KB. Pulmonary Aspiration of Gastric Contents: A Closed Claims Analysis. Anesthesiology. 2021 Aug 1;135(2):284-291. doi: 10.1097/ALN.0000000000003831.

    PMID: 34019629BACKGROUND

  • Cook-Sather SD, Tulloch HV, Cnaan A, Nicolson SC, Cubina ML, Gallagher PR, Schreiner MS. A comparison of awake versus paralyzed tracheal intubation for infants with pyloric stenosis. Anesth Analg. 1998 May;86(5):945-51. doi: 10.1097/00000539-199805000-00006.

    PMID: 9585274BACKGROUND

  • Evain JN, Durand Z, Dilworth K, Sintzel S, Courvoisier A, Mortamet G, Desgranges FP, Bouvet L, Payen JF. Assessing gastric contents in children before general anesthesia for acute extremity fracture: An ultrasound observational cohort study. J Clin Anesth. 2022 May;77:110598. doi: 10.1016/j.jclinane.2021.110598. Epub 2021 Nov 18.

    PMID: 34801888BACKGROUND

  • Spencer AO, Walker AM, Yeung AK, Lardner DR, Yee K, Mulvey JM, Perlas A. Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes. Paediatr Anaesth. 2015 Mar;25(3):301-8. doi: 10.1111/pan.12581. Epub 2014 Dec 11.

    PMID: 25495405BACKGROUND

  • Schmitz A, Schmidt AR, Buehler PK, Schraner T, Fruhauf M, Weiss M, Klaghofer R, Kellenberger CJ. Gastric ultrasound as a preoperative bedside test for residual gastric contents volume in children. Paediatr Anaesth. 2016 Dec;26(12):1157-1164. doi: 10.1111/pan.12993. Epub 2016 Aug 20.

    PMID: 27543559BACKGROUND

  • Raidoo DM, Rocke DA, Brock-Utne JG, Marszalek A, Engelbrecht HE. Critical volume for pulmonary acid aspiration: reappraisal in a primate model. Br J Anaesth. 1990 Aug;65(2):248-50. doi: 10.1093/bja/65.2.248.

    PMID: 2223347BACKGROUND

  • Cook-Sather SD, Liacouras CA, Previte JP, Markakis DA, Schreiner MS. Gastric fluid measurement by blind aspiration in paediatric patients: a gastroscopic evaluation. Can J Anaesth. 1997 Feb;44(2):168-72. doi: 10.1007/BF03013006.

    PMID: 9043730BACKGROUND

  • Bricker SR, McLuckie A, Nightingale DA. Gastric aspirates after trauma in children. Anaesthesia. 1989 Sep;44(9):721-4. doi: 10.1111/j.1365-2044.1989.tb09255.x.

    PMID: 2802116RESULT

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Elaina Lin, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 15, 2022

Study Start

March 26, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

US(1)